Health TrialsbyHealthPanel

Effects of Expiratory Muscle Strength Training in Adolescent Idiopathic Scoliosis

ConditionsAdolescent Idiopathic Scoliosis (AIS)Scoliosis; Adolescence
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10-19
SponsorGazi University

About this trial

Adolescent idiopathic scoliosis result in deterioration of core muscles and respiratory system. Core muscles provide trunk stabilization as well as responsible for respiratory system. Especially tr. abdominis, rectus abdominis, external oblic and internal oblic muscle, which are core muscles, highly active during forced expiration while diaphragm muscle also active during inspiration. Thus, expiratory muscle strength training has effect not only respiratory muscle strength but also trunk stabilization. While, effects of expiratory muscle strength training in adolesecent idiopathic scoliosis is a topic that needs to be investigated, this topic has not been investigated until today. Hence, this current study aimed to investigate the effects of expiratory muscle strength training on cobb angle, respiratory muscle strength, core stabilization, functional exercise capacity and quality of life.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Individuals diagnosed with idiopathic scoliosis,

aged between 10 and 19 years,

with a Cobb angle ranging from 10 to 45 degrees.

Disqualifiers

Individuals who have undergone spinal surgery,

who have received conservative or surgical treatment for scoliosis,

individuals with neurological, neuromuscular, systemic, rheumatological, or musculoskeletal disorders, or conditions affecting balance and walking,

individuals with a history of cardiac or pulmonary diseases that could affect respiratory function and exercise capacity.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Expiratory Muscle Strength Training (EMST-150)

    Device

    Training is going to perform by using a pressure treshold-loading device (EMST-150, Aspire Products, LLC, Gainesville, FL) used to exhale against a same-pressure load every exhalation for strengthening primarily the core muscles. The device pressure is adjusted according to PEmax and reliability/reproducibility has been demonstrated.

  • Sham Training

    Device

    Training is going to perform by using a pressure treshold-loading device (EMST-150, Aspire Products, LLC, Gainesville, FL) without physiological load. The sham device closely resembled the EMST device, with the only difference being that the pressure release valve was rendered nonfunctional by removing the spring. As a result, it exerted minimal to no physiological load on the targeted muscles.

Treatment groups

24 Participants
are divided into 2 treatment groups
Group A: Expiratory Muscle Strength Training GroupActive comparator 1 intervention
Group B: Sham GroupSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Cobb Angle

This is the gold standard method used to assess the lateral curvature of the spine. In this method, participants' anteroposterior radiographic images will be captured while they are in a standing position. The angle between a line drawn parallel to the upper edge of the highest vertebra involved in the scoliosis curve and a line drawn parallel to the lower edge of the lowest vertebra involved will be measured on the radiographic image. These measurements will be performed by an experienced orthopedic physician

Time frame
6 Weeks

Secondary outcomes

1

Respiratory Muscle Strength

The measurement of maximal inspiratory pressures (MIP) and maximal expiratory pressures (MEP), which are voluntarily assessed to evaluate the participants' respiratory muscle strength, will be conducted using an electronic and portable mouth pressure measurement device (Micro Medical MicroRM, UK) in accordance with ATS/ERS criteria.

Time frame
6 Weeks
2

McGill Endurance Test

The participants' core stabilization will be assessed using the McGill Endurance Test.

Time frame
6 Weeks
3

'6 Minute Pegboard and Ring' Test

To assess the functional exercise capacity of the participants, the 'Pegboard and Ring' test will be performed for the upper extremities.

Time frame
6 Weeks
4

Scoliosis Research Society 22 Patient Questionnaire

The participants' quality of life will be assessed using the scoliosis research society 22 patient questionnaire. This questionnaire consists of 22 items and each item is scored between 0-5 point. While, the maximum score that obtained from the questionnaire is 110 point, the minimum score is 0 point. An increase scores on this questionnaire mean that quality of life has improved.

Time frame
6 Weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Gazi University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: